Despite intense research effort and progress in our understanding of the mechanistic and molecular basis of pain, there have been few real breakthroughs in novel analgesic drug development over the past 50 years. One major obstacle to the development of novel pain medicines is the difficulty of planning and executing analgesia clinical trials that meet the expectations of regulatory authorities, ethics committees, and other key stakeholders.
While double-blind randomized controlled trials remain the gold standard for evaluating the efficacy and safety of most medical treatments, they may present a challenge in chronic pain studies due to the placebo response. Placebo analgesia is a robust phenomenon that must be accounted for and mitigated when designing and executing a clinical trial.1
This white paper provides an overview of placebo considerations in chronic pain studies, including strategies for developing rigorous placebo-controlled analgesia clinical trials and tips for reducing response bias and variability.